Clinical Trials

Inclusion Criteria:

• Male and female.
• Aged 18 - 80 years old.
• Biopsy confirmed CD diagnosis (Pathology report confirmation by principal investigator).
• Self-reported adherence to a gluten-free diet for ≥ 12 months (documented by medical history).
• TG2 IgA antibody negative.
• Agree to maintain dosing of approved prescribed and OTC medications throughout the course of the study.
• Willing to take study treatment with each daily evening meal (e.g., dinner).
• Willing to take gluten foodstuff with each daily evening meal (e.g., dinner).
• If using a statin, willing to withhold statin therapy for 48 hours prior to in-clinic simvastatin ingestion and testing.
• Willing to maintain GFD for entire study duration.
• Willing to undergo multiple esophagogastroduodenoscopy procedures during the course of the trial.
• Access to a reliable telephone that would allow MSM dosing compliance telephone calls.
• Access to the internet via smartphone, tablet or computer device or equivalent to facilitate daily (end-of-day) symptom reporting.
• Willing to agree to minimal ingestion outside of three main daily meals.
• Willing to limit snacks outside the daily evening meal (e.g., dinner) to gluten-free snacks.
• Willing to not ingest grapefruit in any form (i.e., whole fruit, pulp, juice, etc.) during the 48 hour period prior to and during study visits 3 & 4.
• Willing and able to comply with all study procedures.
• Must read and understand English.
• Must sign informed consent.

Exclusion Criteria:

• Active dermatitis herpetiformis lesions at the time of screening.
• History of any form of colitis.
• History of IgE-mediated reactions to wheat (i.e., “wheat allergy”).
• Any clinical contraindications to performing an endoscopy with intestinal biopsy.
• Received any systemic biologics (such as monoclonal antibodies or other protein therapeutics where the half-life overlaps with study start) within 6 months prior to study start.
• Taking any oral probiotic supplements (not including probiotics contained in commercially available food preparations) 6 months prior to entry.
• Use of any immunosuppressive medications (i.e., for chronic treatment of autoimmune disease or transplant-rejection prophylaxis) 6 months prior to entry.
• Use of systemic cortisone-like medications within 28-days prior to and during study treatment.
• History of alcohol abuse, illegal drug use (e.g. amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, and opiates) or medical and recreational cannabinoid use within the past 12 months.
• Laboratory values:
  • Elevated liver function tests (Alanine Aminotransferase [ALT], Aspartate Transaminase[AST],Alkaline Phosphatase [Alk Phos], or Gamma-Glutamyl Transferase [GGT]) > 2.5 times the upper limit of normal (ULN);
  • Total bilirubin > 1.5x ULN;
  • Serum creatinine > 1.5x ULN;
  • Hemoglobin < 10 g/dL or 100 g/L;
  • Calcium  < 8.0 mg/mL;
  • Platelet count< 75.0 x 109/L or 75,000/mm3;
  • Partial thromboplastin time (PTT) or prothrombin time (PT/INR) > 1.5 ULN;
  • Serum potassium < 3.0 mmol/L, > 5 mmol/L;
  • Total white blood cell count (WBC)  < 3.0 x 109/L or 3000/mm3;
  • Total lymphocyte < 1.0 x 109/L or 1000/mm3.
• Current untreated or active peptic ulcer disease, Grade B or greater esophagitis, motility disorders such as irritable bowel syndrome, functional dyspepsia, inflammatory bowel disease, and symptomatic GERD (gastroesophageal reflux disease) other than celiac disease.
• Women of Child Bearing Potential (WOCBP): positive urine pregnancy test.
• Unwilling to practice highly effective birth control (unless surgically sterilized or post-menopausal).
• Other than oral contraceptives, use of prescribed medications or over-the-counter medications that, in the opinion of the investigator might interfere with study results.
• Current use of anticoagulants (warfarin sodium, heparin, full-dose aspirin [325 – 650 mg/dose] or clopidogrel) during the 7-day period prior to randomization.
• Currently taking any medication(s) contraindicated for use with simvastatin that cannot be stopped 48 hours prior to visits 3 & 4 and restarted after visits 3 & 4, respectively.
• Received any experimental drug within 30 days of randomization, in the case of experimental biologics at least 6 months prior to randomization.
• The existence of any uncontrolled chronic disease or condition [for example HIV-AIDS, hepatitis, Type 1 or 2 diabetes, or cancer (other than skin cancer)], other than celiac disease.
• Uncontrolled complications of celiac disease, which, in the opinion of the investigator, could affect immune response or pose an increased risk to the patient (e.g. Type 1 diabetes or other autoimmune disease).
• Known allergy or hypersensitivity to any of the components of the placebo, IMGX003 (including sulfites), E. coli, or E. coli-derived proteins and simvastatin.
• Known adverse respiratory effects caused by sulfites.
• Inability to give informed consent.
• Any medical condition, other than celiac disease, which, in the opinion of the investigator, could adversely affect the patient’s participation in the trial.